FDA: Cook recalls all Beacon Tip catheters

Editor's Note

The Food and Drug Administration (FDA) on May 4 announced the recall by Cook Medical (Bloomington, Indiana) of all lots of its catheters with Beacon Tip technology. The catheters are used in angiographic, radiographic, interventional, and urologic procedures.

The catheters have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which has resulted in 30 medical device reports to date. 

Posted 05/04/2016] AUDIENCE: Risk Manager ISSUE: On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date.